Phase
Condition
Mild Cognitive Impairment
Memory Loss
Dementia
Treatment
Dasatinib
Quercetin
Clinical Study ID
Ages > 55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men and women of age 55 years and older at the time of enrollment
Clinical diagnosis of symptomatic probable AD (MMSE 26 to 15 or Short Test of MentalStatus 31 to 15 inclusive and/or Clinical Dementia Rating Scale/CDR = 0.5 to 2,inclusive)
Not on cholinesterase inhibitors or memantine; or if on cholinesterase inhibitorsand/or memantine, on a stable dose for at least three months
Body Mass Index (BMI) within range of 19 - 50 kg/ m2
Participants must be accompanied by a LAR designated to sign informed consent and toprovide study partner reported outcomes at all visits
Participants must have no plans to travel over the ~3 months between Visits 3 and 14that interfere with study visits
Tau positivity by brain PET imaging
Adequate blood counts i.e. platelets > 50,000 per microliter; HB > 9/dL, and ANC > 1000 per microliter
Availability and consent from a LAR.
Exclusion
Exclusion Criteria:
Unwilling or unable to give informed consent
Pregnancy
QTc > 450 msec on baseline ECG
MRI contraindications
Presence of uncontrolled psychiatric disorder (as per clinical judgment)
Presence of uncontrolled systemic lupus erythematosus (as per clinical judgment)
Substance or alcohol abuse (current alcohol use > 3 alcoholic beverage/day or > 21per week and as per clinical judgment)
Hearing, vision, or motor deficits despite corrective devices (as per clinicaljudgment)
Myocardial infarction, angina, stroke, or transient ischemic attack in the past 6months
Chronic heart failure (as per clinical judgment)
Neurologic, musculoskeletal, or other condition that limits subject's ability tocomplete study physical assessments (as per clinical judgment)
Positive SARS-CoV-2 test within 30 days prior to enrollment
AST/ALT > 2.5x upper limit normal
Presence of significant liver disease with total bilirubin > 2X upper limit or asper clinical judgment
Inability to tolerate oral medication (as per clinical judgment)
Abnormality in any of the screening laboratory studies (see section 6.21.2) or asper clinical judgment
Malabsorption (as per clinical judgment)
Known human immunodeficiency virus infection (as per clinical judgment)
Known active hepatitis B or C infection
Invasive fungal or viral infection (as per clinical judgment)
Known hypersensitivity or allergy to D or Q
Uncontrolled pleural/pericardial effusions or ascites (as per clinical judgment)
New/active invasive cancer except non-melanoma skin cancers
Inability to tolerate oral medications (as per clinical judgment)
Currently taking AND unable to safely hold any of the medications listed in Appendix 1 during the days IP is administered and for 36 hours after IP administration.
Uncontrolled diabetes (defined as HbA1c > 7% or as per clinical judgment).
Gastric bypass/reduction
Crohn's disease
Myopathies (increased or low calcium, vitamin D deficiency, elevated creatine kinaseor ESR) (as per clinical judgment)
eGFR < 10 ml/ min/ 1.73 m2
Creatinine clearance < 60 mL/min/1.73 m2
Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, lowmolecular weight heparin, factor Xa inhibitors, etc.)
On antiplatelet agents (e.g., full dose Aspirin, Clopidogrel etc.). Baby aspirin (81mg), if absolutely necessary from cardiac perspective, will be allowed
Presence of any condition that the Investigator believes would put the subject atrisk or would preclude the patient from successfully completing all aspects of thetrial
Involvement of special vulnerable populations: We will not involve special vulnerable populations, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations except for patients with dementia. Therefore, availability and consent from a LAR is an inclusion criterion.
Study Design
Study Description
Connect with a study center
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
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